50 mg Capsule 150 mg Capsule Fluconazole

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50 mg Capsule 150 mg Capsule Fluconazole
ZOLEN
50 mg Capsule
150 mg Capsule
Fluconazole
DESCRIPTION
ZOLEN (Fluconazole) is a broad-spectrum antifungal of Triazole subclass. Fluconazole exerts its antifungal
activity by inhibiting the synthesis of ergosterol, a major component of the cell membrane of yeast and
fungi. Fluconazole is used for superficial mucosal candidiasis, fungal skin infections, systemic fungal
infections and has been tried in blastomycosis, chromoblastomycosis, histoplasmosis, sporotrichosis, and
cutaneous leishmaniasis.
COMPOSITION
ZOLEN-50 Capsule : Each capsule contains Fluconazole BP 50 mg.
ZOLEN-150 Capsule : Each capsule contains Fluconazole BP 150 mg.
INDICATION
ZOLEN (Fluconazole) is indicated for the treatment of the following infections :
l Vaginal candidiasis and candidal balanitis
l Mucosal candidiasis including oropharyngeal candidiasis, atrophic oral candidiasis associated with dentures
l Other mucosal infections (e.g. oesophagitis, candiduria, non-invasive bronchopulmonary infections)
l Tenia pedis, corporis, cruris, pityriasis versicolor and dermal candidiasis
l Systemic/Invasive candidal infections (including candidaemia and disseminated candidiasis) and
cryptococcal infections (including meningitis)
l Prevention of relapse of cryptococcal meningitis in AIDS patients
l Prevention of fungal infections in immunocompromised patients
l Urinary tract infection and peritonitis
l Cutaneous leishmaniasis
DOSAGE AND ADMINISTRATION
Adults: .
Infections
Dose
Treatment Duration
Vaginal candidiasis and candidal balanitis
a single dose of 150 mg.
Oropharyngeal candidiasis *
50 mg once daily
7-14 days
Atrophic oral candidiasis associated with dentures
50 mg once daily
14 days
Other mucosal infections (e.g. oesophagitis*,
candiduria, non-invasive bronchopulmonary infections)
50 mg once daily
14-30 days
Tenia pedis, corporis, cruris, pityriasis versicolor,
and dermal candidiasis
50 mg once daily
Systemic/Invasive candidal infections (including
candidaemia, disseminated candidiasis, pneumonia)
and cryptococcal infections (including meningitis)
400 mg initially then 200
mg daily, increased if
necessary to 400 mg daily
2-4 weeks (for up to 6 weeks in
tenia pedis)
Treatment continued according
to response (at least 6-8 weeks
for cryptococcal meningitis)**
Prevention of relapse of cryptococcal meningitis in
AIDS patients
100 mg to 200 mg daily
Prevention of fungal infections in
immunocompromised patients
50-400 mg daily adjusted according to risk; 400 mg daily if high risk
of systemic infections e.g. following bone-marrow transplantation;
commence treatment before anticipated onset of neutropenia and
continue for 7 days after neutrophil count in desirable range.
Urinary tract infection and peritonitis
50-200 mg daily
Cutaneous leishmaniasis
200 mg daily
* Higher doses are recommended in the USA where an initial dose of Fluconazole 200 mg is followed by
100 mg daily and doses up to 400 mg daily may be used if necessary.** In the USA 10-12 weeks.
Children (over 4 weeks) : Mucosal candidiasis : 6 mg/kg on first day then 3 mg/kg daily. Systemic/Invasive
candidal infections (including candidaemia and disseminated candidiasis) and cryptococcal infections
(including meningitis) :12 mg/kg on first day then 6 mg/kg daily. Prevention of fungal infections in
immunocompromised patients : according to extent and duration of neutropenia, 3-12 mg/kg daily.
Infant (2-4 weeks) : Same dose of older children (over 4 weeks) but every 48 hours.
Infant (under 2 weeks) : Same dose of older children (over 4 weeks) but every 72 hours.
A maximum dose of 400 mg daily should not be exceed in children or 12 mg/kg at appropriate intervals in infants.
In renal impairment : Normal loading or initial doses of Fluconazole should be given on the first day of
treatment and subsequent doses should be adjusted according to Creatinine Clearance (CC). CC >50 ml/min:
standard dose; CC <50 ml/min and the patient is not receiving dialysis: ½ the standard dose; patients on regular
haemodialysis: standard dose after every dialysis session. No dosage adjustment is needed in single-dose
therapy.
CONTRAINDICATION
ZOLEN is contraindicated in known hypersensitivity to Fluconazole or other Azole antifungal agents and in
advanced liver disease.
PRECAUTION
ZOLEN (Fluconazole) should be used with caution in renal or hepatic impairment, arrhythmic conditions.
IN PREGNANCY AND LACTATION
Pregnancy : Pregnancy category C. There are no adequate and well controlled studies of Fluconazole in
pregnant women. Fluconazole should be considered only if the expected benefit to the mother is greater than
any possible risk to the foetus. Lactation : Fluconazole is secreted in breast-milk at concentrations similar to
plasma. Because of the potential for adverse reactions in nursing infants, decide whether to discontinue
nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
SIDE EFFECTS
Nausea and vomiting, abdominal discomfort, diarrhoea, flatulence, taste disturbance, headache, dizziness,
leucopenia, thrombocytopenia, hyperlipidaemia, rash, anaphylaxis, rash, pruritus, toxic epidermal
necrolysis, Stevens-Johnson syndrome, alopecia, hypokalemia, QT prolongation, hepatic toxicity.
DRUG INTERACTION
Oral hypoglycemics (Tolbutamide, Glyburide, Glipizide, Nateglinide) : plasma concentration of these agents
are increased, therefore hypoglycemia may be precipitated. Coumarin-type anticoagulants (Warfarin) :
prothrombin-time may be increased. Cyclosporine, Phenytoin, Rifabutin, Tacrolimus, Zidovudine : plasma
concentration of these agents are increased. Benzodiazepines (Midazolam, Triazolam), Nortriptylin :
plasma concentration of these agents are increased. Astemizole, Cisapride, Terfenadine : risk of cardiac
arrhythmias. Rifampicin : reduces plasma concentration of Fluconazole. Theophylline : may reduce the
clearance of theophylline. Oral contraceptives : the efficacy of oral contraceptives may be affected.
STORAGE
Store in a cool dry place and away from light. Keep out of the reach of children.
HOW SUPPLIED
ZOLEN-50 Capsule
: Box containing 5 x 10's capsule in Alu-PVC blister strips.
ZOLEN-150 Capsule : Box containing 1 x 10's capsule in Alu-PVC blister strip.
Manufactured by
Apex Pharma Ltd.
6 weeks
Shafipur, Gazipur

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